Gilead’s Trodelvy (sacituzumab govitecan) Receives EC’s Approval for Pre-Treated HR+/HER2- Metastatic Breast Cancer
- The EC has approved Trodelvy as a monotx. for adult patients with unresectable or metastatic HR+ HER2- breast cancer who have received endocrine-based therapy & 2 additional systemic therapies in the advanced setting
- The approval was based on the P-III study (TROPiCS-02) evaluating Trodelvy vs CT in a ratio (1:1) in 543 patients, showed a significant & clinical OS benefit (3.2mos.), m-OS (14.4 vs 11.2mos.), 34% reduction in risk of disease progression or death, m-PFS (5.5 vs 4.0mos.) people were progression-free at 1yr. (21% vs 7%)
- Improvement in additional 2EPs measures, incl. ORR, TTD with no significant difference in TTD in Pain Scale. The safety profile was consistent with prior studies with no new safety signals, adverse reactions leading to treatment discontinuation (6% vs 4%)
Ref: Gilead | Image: Gilead
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